Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00534326

Acronym

STAFF

Enrollment

158

Registered

2007-09-24

Start date

2006-12-31

Completion date

2018-12-30

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Fractures

Brief summary

Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based outcomes on these patients. Little information exists on the patient based outcomes following femur fractures. We hope that the patient based outcomes of this study will also be able to aid physicians in advising patients with femur fractures of their possible outcomes.

Interventions

PROCEDUREStandard Reaming

Femoral reaming using standard reaming techniques of multiple reamers

PROCEDUREReaming/Irrigating/Aspirating

Reaming using the Reamer/Irrigator/Aspirating

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Men or women between the ages of 18 years and 85 years; 2. Acute fractures of the femoral shaft

Exclusion criteria

1. Fractures not amenable to intramedullary nailing and deemed by the treating surgeon; 2. Pathological fractures; 3. Open fractures; 4. Patients with additional injuries to the ipsilateral femur; 5. Surgical delay of greater than 7 days from the time of injury; 6. Retained hardware in the affected limb; 7. Previous infection in fractured limb; 8. Likely problems in the judgment of the investigators with maintaining follow-up; 9. Patients with severe cognitive injuries or disabilities will be excluded if it is deemed that they will be unable to complete the study questionnaires; 10. Hopeless diagnosis; 11. Medical comorbidities that prohibit the conductance of surgical treatment under a general anesthetic; 12. Fractures requiring cephalomedullary nails

Design outcomes

Primary

Measure	Time frame
Fracture Healing	3 months, 6 months, 1 year, 2 years

Secondary

Measure	Time frame
Patient Based Quality of Life	Baseline, 3 months, 6 months, 1 year, 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026